Retraction of tissue for single port entry, robotically assisted medical procedures

ABSTRACT

A single port entry surgical instrument has an elongated structure with lumens through which surgical tools and an image capturing device may be inserted and controllably extended out of its distal end for performing a medical procedure, a tubular-shaped balloon disposed around the elongated structure, and an expandable retractor disposed around the balloon so that when the balloon is inflated, the retractor expands and locks in an expanded configuration to retract extraneous tissue. The port entry may be secured using the expandable retractor or sealed using another inflatable balloon disposed around the proximal end of the elongated structure and centered in the port entry.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. provisional application Ser.No. 60/813,198 filed Jun. 13, 2006, which is incorporated herein byreference.

FIELD OF THE INVENTION

The present invention generally relates to the retraction of tissueduring medical procedures and in particular, to apparatuses and methodsfor the retraction of tissue for single port entry, robotically assistedmedical procedures.

BACKGROUND OF THE INVENTION

Medical robotic systems such as telesurgical systems used in performingminimally invasive surgical procedures offer many benefits overtraditional open surgery techniques, including less pain, shorterhospital stays, quicker return to normal activities, minimal scarring,reduced recovery time, and less injury to tissue. Consequently, demandfor such medical robotic systems is strong and growing.

Examples of medical robotic systems include the da Vinci® SurgicalSystem and the da Vinci® S™ Surgical System from Intuitive Surgical,Inc., of Sunnyvale, Calif. Each of these systems includes a surgeon'sconsole, a patient-side cart, a high performance three-dimensional(“3-D”) vision system, and Intuitive Surgical's proprietary EndoWrist®articulating instruments, which are modeled after the human wrist. Whenadded to the motions of manipulators holding the surgical instruments,these articulating instruments allow at least six degrees of freedom ofmotion to their end effectors, which is comparable to or even greaterthan the natural motions of open surgery.

In conventional medical robotic systems, each medical device such as asurgical tool or image capturing device is typically manipulated by aseparate robotic arm and is directed to a surgical site within a patientthrough its own minimally invasive incision. When it is desirable toretract extraneous tissue in order to access a target tissue to performa medical procedure, it may be a simple matter to employ an extrarobotic arm or human assistant to manipulate a retractor, such as shownin FIGS. 1˜2, where instruments 101, 102 gain clear physical access andimage capturing device 103 gains clear visible access to target tissue104 by employing a conventional retractor 201 which is used to pullextraneous tissue 105 out of their way.

When only a single entry port is available for performing a medicalprocedure, however, retraction of extraneous tissue is not so simple amatter. First of all, the medical device in such case may be a surgicalinstrument that includes more than one surgical tool as well as possiblyan image capturing device that are controllably extendable andmanipulatable: out of a distal end of the surgical instrument. If theretractor is a separate tool, then trying to fit it through the sameport as the surgical instrument is generally not feasible due to thelimited size of the port (which may be an incision or a natural bodyorifice).

On the other hand, adding a retractor as an additional surgical tool tothe single port entry surgical instrument so that the additional tool isalso controllably extendable and manipulatable out of the distal end ofthe surgical instrument is also not generally feasible due again to thelimited diameter of the single port entry which in turn, places a limiton the maximum diameter of the surgical instrument. Even if it werefeasible to add the retractor as an additional tool to the surgicalinstrument, it may not be possible for the retractor to physically reachthe tissue to be retracted while the other surgical tools are performinga medical procedure on the target tissue due to the physical coupling,of the tools of the surgical instrument. In addition, even if theretractor tool was able to reach the extraneous tissue and havesufficient available extension to move it out of the way, it may bedifficult for the retractor to exert the necessary force to do sobecause of a lack of leverage in its construction.

OBJECTS AND SUMMARY OF THE INVENTION

Accordingly, one object of one or more aspects of the present inventionis a device for retracting tissue during a medical procedure performedusing only a single port entry in the patient's body.

Another object of one or more aspects of the present invention is amethod for retracting tissue during a medical procedure performed usingonly a single port entry in the patient's body.

These and additional objects are accomplished by the various aspects ofthe present invention, wherein briefly stated, one aspect is a surgicalinstrument comprising: an elongated structure having proximal and distalends and a first lumen extending between the proximal and distal ends; asurgical tool inserted within the first lumen, wherein the surgical toolhas a distal end adapted with an end effector and a proximal end adaptedwith an interface for controllably manipulating the end effector forperforming a medical procedure; a balloon disposed around an outersurface of the elongated structure; and an expandable retractor disposedaround an outer surface of the balloon so that the expandable retractoris expanded and locks in an expanded configuration when the balloon isexpanded to sufficient volume.

Another aspect is a method for retracting extraneous tissue using asurgical instrument configured with a balloon disposed around thesurgical instrument so that the surgical instrument extends within acore formed in the balloon, and an expandable retractor disposed aroundthe balloon so that the expandable retractor is expanded and locks in anexpanded configuration when the balloon is expanded to sufficientvolume, comprising: robotically positioning the surgical instrument sothat the expandable retractor retracts the extraneous tissue when theexpandable retractor is expanded to and locked in its expandedconfiguration; expanding the balloon so that the expandable retractor isexpanded to and locked in its expanded configuration; deflating theballoon; and robotically moving an end effector of the surgicalinstrument towards a target tissue while the expanded retractor remainslocked and in place so as to continue retracting the extraneous tissue.

Another aspect is a method for securing an entry port for a surgicalinstrument through an anatomic structure, wherein the surgicalinstrument is configured with a tubular-shaped balloon disposed aroundthe surgical instrument so that the surgical instrument extends within acore formed in the tubular-shaped balloon, and a retractor disposedaround the tubular-shaped balloon in an unexpanded configuration havingan outer diameter less than an inner diameter of the entry port andexpandable so that the retractor is expanded and locks in an expandedconfiguration having an outer diameter slightly more than the innerdiameter of the entry port when the tubular-shaped balloon is expandedto sufficient volume, comprising: robotically positioning the surgicalinstrument so that the retractor in its unexpanded configuration isapproximately centered in the entry port; expanding the tubular-shapedballoon so that the retractor is expanded to and locked in its expandedconfiguration; deflating the tubular-shaped balloon; and roboticallymoving the surgical instrument towards a target tissue while theretractor remains in its expanded configuration to secure the entryport.

Another aspect is a method for sealing an entry port for a surgicalinstrument through an anatomic structure, wherein the surgicalinstrument is configured with a tubular-shaped balloon disposed aroundthe surgical instrument so that the surgical instrument extends within acore formed in the tubular-shaped balloon, comprising: roboticallypositioning the surgical instrument so that the tubular-shaped balloonin its unexpanded configuration is approximately centered in the entryport; and expanding the tubular-shaped balloon so that the expandedtubular-shaped balloon forms a seal around the entry port; androbotically moving an end effector of the surgical instrument towards atarget tissue for performing a medical procedure on the target tissueusing the end effector.

Additional objects, features and advantages of the various aspects ofthe present invention will become apparent from the followingdescription of its preferred embodiment, which description should betaken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1˜2 illustrate simplified top views of a surgical site before andafter performing conventional retraction of extraneous tissue.

FIGS. 3˜4 illustrate simplified top and cross-sectional views of asurgical instrument with a balloon expandable retractor utilizingaspects of the present invention.

FIGS. 5˜6 illustrate simplified top and cross-sectional views of asurgical instrument with a balloon expanded retractor utilizing aspectsof the present invention.

FIG. 7 illustrates a perspective view of a distal end of a surgicalinstrument utilizing aspects of the present invention.

FIG. 8 illustrates a flow diagram of a method for retracting tissueusing a surgical instrument with a balloon expandable retractor,utilizing aspects of the present invention.

FIGS. 9˜14 illustrate simplified top views of a surgical site as asurgical instrument, which is adapted with a balloon expandableretractor utilizing aspects of the present invention, deploys itsretractor for performing a medical procedure.

FIGS. 15˜17 illustrate simplified side views of an entry port to acavity of a patient's body as a surgical instrument deploys a retractorto secure the entry port, utilizing aspects of the present invention.

FIGS. 18˜19 illustrate simplified side views of an entry port to acavity of a patient's body as a surgical instrument deploys a balloon toseal the entry port, utilizing aspects of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIGS. 3˜7 illustrate simplified examples of various views of a surgicalinstrument 300 adapted for single port entry into a patient forperforming a medical procedure on target tissue. In particular, FIGS.3˜4 illustrate top and cross-sectional views of the surgical instrument300 in its deflated balloon and collapsed retractor configuration, FIGS.5˜6 illustrate top and cross-sectional views of the surgical instrument300 in its expanded balloon and retractor configuration, and FIG. 7illustrates a perspective view of a distal end 304 of the surgicalinstrument 300.

The surgical instrument 300 includes an elongated structure 301 (alsoreferred to herein as a “tool guide” or an “elongated tool guidestructure”) having a generally convex cross-section such as a cylinder.A balloon 302 is disposed around the elongated structure 301 and istubular in shape so that when it is deflated, the elongated structure301 snugly fits in a central core of the tubular-shaped balloon 302. Anexpandable retractor 303 is disposed around the tubular-shaped balloon302. The retractor 303 is preferably like a hollow cylinder in shape sothat when it is collapsed, the tubular-shaped balloon 302 fits snugly inthe hollow of the retractor 303. The retractor 303 is furtherconstructed so that as the balloon 302 inflates, the retractor 303expands accordingly, like an expandable stent, until the balloon 302reaches a certain volume, at which time the retractor 303 locks in itsexpanded configuration where it no longer expands and remains at thatexpansion size even after the balloon 302 is deflated and the retractor303 is no longer in physical contact with the rest of the surgicalinstrument 300.

The tool guide 301 has a plurality of lumens 311˜314 extending betweenits distal and proximal ends 304, 305. The lumens 311-314 shown in FIGS.4, 6 are illustrative of various diameters and geometric cross sections.In an exemplary configuration, a pair of surgical tools 321, 331 areinserted in lumens 311, 312, and an image capturing device 341 insertedin lumen 313. The surgical tools 321, 331 have distal ends adapted withend effectors 322, 332, and proximal ends adapted with interfaces (notshown) for control purposes. The image capturing device 341 has a distalend adapted with a stereoscopic camera pair 342, 343 and a light emitter344, and it has a proximal end adapted with an interface (not shown) forcontrol as well as image capturing, processing and transmissionpurposes.

The interfaces for the surgical tools 321, 331 and the image capturingdevice 341 are coupled to one or more processors in a medical roboticsystem so that the surgical tools 321, 331 (and their end effectors) maybe robotically manipulated by a surgeon using hand-manipulated inputcontrol devices (i.e., teleoperated) while viewing three-dimensional(3-D) images of the surgical site as captured by the image capturingdevice 341 and viewed on a 3-D monitor, such as generally described, forexample, in commonly owned U.S. Pat. No. 6,671,581 “Camera ReferencedControl in a Minimally Invasive Surgical Apparatus,” which isincorporated herein by reference, with the exception that the surgicaltools 321, 331 and the image capturing device 341 all enter the patientthrough a single entry port as part of the surgical instrument 300rather than through individually assigned entry ports as described inthe reference.

FIG. 8 illustrates, as an example, a flow diagram of a method forretracting tissue using the surgical instrument 300, and FIGS. 9˜14illustrate, as an aid in describing the method, simplified top views ofthe surgical site as the surgical instrument 300 deploys itsballoon-expandable retractor 303 to perform a medical procedure.

In 801, the surgical instrument 300, in its unexpanded configuration asshown and described in reference to FIGS. 3˜4, is robotically movedtowards the target tissue 390 as shown in FIG. 9, and positionedadjacent extraneous tissue 370, 380 which are to be retracted in orderto provide accessibility to and/or better visibility of the targettissue 390.

In 802, once the surgical instrument 300 is properly positioned forretraction of the extraneous tissue 370, 380, the balloon 302 isexpanded by filling it with a gas or liquid using a tube (not shown)running, e.g., along the outer surface of the surgical instrument 300and connected to a gas or liquid source (not shown). In turn theexpanding balloon 302 causes the retractor 303 to expand and lock in itsexpanded configuration after the balloon 302 reaches sufficient volume,as shown and described in reference to FIGS. 5˜6. Consequently,retractor 303 retracts the extraneous tissue 370, 380 by spreading themapart as shown in FIG. 10. At this point, the forcing apart of theextraneous tissue 370, 380 results in counter forces that may hold theexpanded retractor 303 in place even after the balloon 302 is deflatedand the expanded retractor 303 is no longer in physical contact with therest of the surgical instrument 300.

In 803, the balloon is deflated and in 804, the surgical instrument 300is moved towards the target tissue 390 while leaving the expanded andlocked retractor 303 in place so as to continue retracting tissue 370,380, as shown in FIG. 11. Once the surgical instrument 300 is in properposition to perform the medical procedure on the target tissue 390, in805, the balloon 302 may optionally be re-inflated so that at least partof it is being forced against the inner surface of the expandedretractor 303, such as shown in FIG. 12. In this way, the retractor 303now additionally serves as a brace for the rest of the surgicalinstrument 300 and in particular, provides a stable platform for itssurgical tools 321, 331 and image capturing device 341 during theperformance of the medical procedure.

In 806, the end effectors of the surgical tools 321, 331 are roboticallymanipulated by the surgeon to perform the medical procedure on thetarget tissue 390 while viewing a monitor in which captured images fromthe image capturing device 341 are viewed. To enhance the quality,contrast, and or color of the images being captured, the outer surfaceof the balloon 302 may have a mirror-like or highly reflective coatingsuch as conventionally used for reflectors in photography. This highlyreflective coating serves to re-reflect light originating at lightemitter 344, which is then reflected by surrounding tissue, back towardsthe target tissue 390.

Once the medical procedure is completed, if the balloon was previouslyinflated in 805, then in 807, it is deflated. In 808, the surgicalinstrument 300 is moved back towards the expanded retractor 303, and in809, the expanded retractor 303 is unlocked and collapsed. As an exampleof this last procedure, FIG. 13 illustrates an end effector of one ofthe surgical tools 321, 331 grabbing and pulling on a string 307 (orother extending element) which is attached to the retractor 303 and usedfor causing the expanded retractor 303 to collapse by, for example,collapsing a key strut which keeps the retractor 303 in its lockedconfiguration.

In 810, the surgical instrument 300 is then robotically removed from thepatient in a conventional manner with the end effector still graspingthe string 307 so that the collapsed retractor 303 may be pulled out viathe incision or natural orifice in a manner similar to removing a tissuecapture bag, as shown in FIG. 14.

As an alternative to collapsing the expandable retractor 303 so that itcan be removed along with the surgical instrument 300, as described inreference to 809˜810 of FIG. 8, the retractor 303 may be left in itsexpanded configuration in the patient if it is formed of a biodegradableor bioabsorbable material and it is left in a part of the body thatallows it to dissolve naturally over time, or if it is formed of amaterial that is non-absorbable until exposed to an activator chemicalwhich breaks down the material allowing controlled dissolution and it isleft in a part of the body where the activator chemical can be safelyintroduced.

A method for securing an entry port 1600 (natural or surgically formed)for a surgical instrument 1500 through an anatomic structure 1601 isillustrated by FIGS. 15˜17, in which simplified side views of the entryport 1600 to a cavity or other area of a patient's body are illustratedas the surgical instrument 1500 deploys an expandable retractor 1503 tosecure and protect the entry port 1600, such as a cannula secures andprotects an incision in a patient's body when installed for performinglaparoscopic surgery. As just one example of its use, proceduresinvolving transluminal incisions and passage may benefit from suchstenting protection.

Starting with FIG. 15, the surgical instrument 1500 is shown beingrobotically positioned within the entry port 1600 so that its retractor1503 is approximately centered in the entry port 1600. As shown in FIG.16, a tubular-shaped balloon 1502 disposed around an elongated toolguide structure 1501 of the surgical instrument 1500 is then expanded,which in turn causes the retractor 1503, which is disposed around theballoon 1502, to expand and be locked in its expanded configuration, ina manner substantially the same as described in reference to 802 of FIG.8. The cross-sectional diameter of the retractor 1503 in its expandedconfiguration is designed in this case so as to be slightly larger thanthe diameter of the entry port 1600 so as to ensure that the expandedretractor 1503 remains firmly in the entry port 1600 thereby appearingand functioning as a grommet. As shown in FIG. 17, the balloon 1502 isthen deflated and the surgical instrument 1500 robotically moved towardsa surgical site within the patient, leaving the retractor 1503 firmlyentrenched in the entry port 1600 so as to secure it to make sure thatit remains open and protected as the surgical instrument 1500 enters,passes through and exits the entry port 1600 during the process ofperforming a medical procedure on a patient. Removal of the retractor1503 may be performed by collapsing and subsequently removing it, suchas described, for example, in reference to 808˜809 of FIG. 8.

A method for sealing an entry port 1800 through an anatomic structure1801 is illustrated by FIGS. 18˜19, in which simplified side views ofthe entry port 1800 to a cavity of a patient's body are illustrated asthe surgical instrument 1900 deploys a balloon 1902 to seal the entryport 1800. Starting with FIG. 18, the surgical instrument 1900 is shownas being robotically positioned within the entry port 1800 so that itstubular or other suitably shaped, deflated balloon 1902 is approximatelycentered in the entry port 1800. As shown in FIG. 19, the balloon 1902is then expanded (using a gas or liquid tube extending along the lengthof the surgical instrument 1900 to an external gas or liquid source) soas to form an air-tight or fluid-tight seal around the entry port 1800.The body cavity may then be insufflated with a gas provided through alumen formed within the elongated tool guide structure 1901 or a tubeextending along its length. The surgical instrument 1900 may also beextended forward to a surgical site within the patient with the innersurface of the expanded balloon 1902 sliding along the outer surface ofelongated tool guide structure 1901. Alternatively, only its endeffector may be robotically extended forward with the elongated toolguide structure 1901 remaining in place. Subsequent removal of theballoon 1902 may be performed after the medical procedure by deflatingit so that it collapses back onto the elongated structure 1901 allowingit to pass through the entry port 1800 and be removed with the surgicalinstrument 1900.

Although the various aspects of the present invention have beendescribed with respect to a preferred embodiment, it will be understoodthat the invention is entitled to full protection within the full scopeof the appended claims.

1-18. (canceled)
 19. A method for securing an entry port for a surgicalinstrument through an anatomic structure, wherein the surgicalinstrument includes a tool guide, a tubular-shaped balloon, and aretractor, wherein the tubular-shaped balloon is disposed around thetool guide so that the tool guide extends within a core formed in thetubular-shaped balloon, wherein the retractor is disposed around thetubular-shaped balloon in an unexpanded configuration while thetubular-shaped balloon is in a deflated condition in which an outerdiameter of the tubular-shaped balloon is less than an inner diameter ofthe entry port, and wherein the retractor is expandable and lockable sothat the retractor is expanded and locks in an expanded configurationwhen the tubular-shaped balloon is in an inflated condition that causesan outer diameter of the retractor to be pressed against and held inplace by an inner wall of the entry port, the method comprising:positioning the surgical instrument so that the retractor in itsunexpanded configuration is disposed within the entry port; expandingthe tubular-shaped balloon so that the retractor is expanded to andlocked in its expanded configuration; deflating the tubular-shapedballoon while the retractor remains in its expanded configuration andheld in place to secure the entry port; and moving the tool guidetowards a target tissue.
 20. The method according to claim 19, furthercomprising: manipulating a tool inserted in the tool guide to cut a holethrough the body structure so as to form the entry port prior todisposing the retractor within the entry port.
 21. The method accordingto claim 19, further comprising: performing a medical procedure on thetarget tissue using a tool inserted in the tool guide; moving the toolguide and the tool back towards the entry port after performing themedical procedure; and manipulating the tool to interact with theretractor so as to collapse the retractor from its expandedconfiguration.
 22. A method for sealing an entry port for a surgicalinstrument through an anatomic structure, wherein the surgicalinstrument includes a tool guide, a tubular-shaped balloon, and aretractor, wherein the tubular-shaped balloon is disposed around thetool guide so that the tool guide extends within a core formed in thetubular-shaped balloon, comprising: positioning the surgical instrumentso that the tubular-shaped balloon in its unexpanded configuration isapproximately centered in the entry port; expanding the tubular-shapedballoon so that the expanded tubular-shaped balloon forms a seal withinthe entry port; and moving a tool inserted in the tool guide towards atarget tissue for performing a medical procedure on the target tissue.23. The method according to claim 22, further comprising: insufflating abody cavity, which is sealed at the entry port by the expandedtubular-shaped balloon, by using a gas provided through a lumen of thesurgical instrument.
 24. The method according to claim 23, furthercomprising: deflating the tubular-shaped balloon after completing themedical procedure so as to remove the seal formed within the entry port;and removing the surgical instrument out of the body cavity through theentry port.